Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MGD007+ MGA012 · 1 trial · 1 indication
Adverse Events, Serious Adverse Events
| Arm | Type | Description |
|---|---|---|
| MGD007 + MGA012 | EXPERIMENTAL | MGD007 is a gpA33 x CD3 bi-specific DART antibody; MGA012 is an anti-PD-1 monoclonal antibody. |
| Name | Type | Description |
|---|---|---|
| MGD007 + MGA012 | BIOLOGICAL | MGD007 and MGA012 are administered by IV infusion. |
Inclusion Criteria: * Histologically proven, relapsed/refractory metastatic colorectal cancer * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Measurable disease per RECIST 1.1 criteria * Participants in the Dose Escalation Phase must have had recurrence, progression or intol...
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MGD007 is an investigational oncology drug being studied for the treatment of colorectal carcinoma and metastatic colorectal cancer. It has been evaluated in patients with relapsed or refractory disease, meaning cancer that has returned or not responded to prior treatments. The drug is currently in clinical development and is not approved by regulatory authorities.
MGD007 is being developed by MacroGenics, Inc., a biopharmaceutical company. MacroGenics is publicly traded on the NASDAQ under the ticker symbol MGNX. The company is conducting clinical trials to evaluate the safety and efficacy of MGD007 in patients with colorectal cancer.
MGD007 is in Phase 1 clinical development. Two Phase 1 trials have been completed, one studying MGD007 as a monotherapy and another studying it in combination with MGA012. The drug remains investigational and has not received FDA approval for any indication.
MGD007 has been studied in two completed Phase 1 clinical trials. The first, NCT02248805, evaluated MGD007 alone in patients with relapsed or refractory metastatic colorectal carcinoma. The second, NCT03531632, studied MGD007 in combination with MGA012 in patients with relapsed or refractory metastatic colorectal cancer. Both trials were conducted in the United States.
No, MGD007 and MGA012 are different investigational drugs. MGD007 is being studied as a monotherapy and in combination with MGA012. A completed Phase 1 trial, NCT03531632, evaluated the combination of MGD007 and MGA012 in patients with relapsed or refractory metastatic colorectal cancer.